Aston v. Johnson & Johnson
248 F. Supp. 3d 43
| D.D.C. | 2017Background
- Five plaintiffs allege serious, multi-system injuries from taking Levaquin (levofloxacin) and claim its label inadequately warned of risks; plaintiffs seek large compensatory and punitive damages.
- Defendants: Johnson & Johnson and related J&J entities (manufacturer), Renaissance Technologies and its principals (alleged investor beneficiaries), and Dr. Margaret Hamburg (former FDA Commissioner, sued individually).
- Plaintiffs allege a broad conspiracy and racketeering scheme: defendants, including Dr. Hamburg, suppressed an April 2013 FDA scientist report linking fluoroquinolones to mitochondrial toxicity to protect J&J stock and obtain bribes.
- Pleading gaps: complaint fails to specify when each plaintiff took Levaquin, which label warnings applied at those times, which plaintiff experienced which symptoms, or who paid for the drug.
- Procedural posture: defendants moved to dismiss; court applied Rule 12(b)(6) and Rule 9(b) standards and granted motions, dismissing all counts for multiple pleading and substantive deficiencies.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Federal RICO standing / proximate cause | Plaintiffs claim injuries (lost earnings) and allege defendants’ RICO conspiracy caused plaintiffs to ingest Levaquin | RICO §1964(c) requires injury to "business or property" (not personal injury); plaintiffs’ injuries are personal and lacking proximate causation from alleged 2013 cover-up | Dismissed: personal injuries (and derivative pecuniary losses) are not RICO "business or property" injuries; alleged 2013 suppression cannot plausibly have caused earlier injuries, so proximate causation fails |
| Arizona RICO claim | State RICO parallels federal RICO; plaintiffs assert same theory under Arizona law | Arizona RICO requires proximate causation from predicate acts; plaintiffs fail for same reasons as federal claim | Dismissed: fails for same proximate-cause deficiency |
| Lanham Act false-advertising | Plaintiffs assert J&J made false/misleading statements that deceived consumers | Lanham Act protects commercial interests (reputation/sales), not consumer personal-injury claims | Dismissed: plaintiff lacks commercial injury in statute’s zone of interests |
| Products-liability & failure-to-warn / design-defect | Plaintiffs contend Levaquin was defective, inadequately labeled, and could have been designed differently | Complaint lacks specific facts on which label applied, timing, reliance, or dose; Mutual Pharm. preempts state design-defect claims requiring label/composition changes | Dismissed: manufacturing, warning, and design-defect claims inadequately pleaded or preempted |
Key Cases Cited
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (plausibility standard for pleadings; courts need not accept legal conclusions)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (plausibility pleading standard applies to antitrust and broader contexts)
- Lexmark Int'l, Inc. v. Static Control Components, Inc., 134 S. Ct. 1377 (2014) (Lanham Act requires plaintiff to allege commercial injury within statute’s zone of interests; RICO proximate-cause discussion referenced)
- Reiter v. Sonotone Corp., 442 U.S. 330 (1979) (interpretation that "business or property" excludes personal injuries)
- Sedima, S.P.R.L. v. Imrex Co., 473 U.S. 479 (1985) (RICO civil cause of action interpretation; standing requires statutory injury element)
- RJR Nabisco, Inc. v. European Cmty., 136 S. Ct. 2090 (2016) (background on RICO’s structure and scope)
- Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013) (state-law design-defect claims that would require changing drug composition or labeling are preempted)